1. Field of the invention
The present invention relates to compositions suitable for the regression of chronic inflammatory skin disorders. In particular, the present invention relates to compositions that have been proven to be safe and effective when used for the regression of chronic inflammatory skin disorders, such as eczema, psoriasis and seborrheic dermatitis.
2. Brief Description of the Background Art
With the changing environment, food habits and lifestyle, incidences of chronic inflammatory skin disorders like eczema, psoriasis and seborrheic dermatitis are on the rise. In tandem, the cost of managing these diseases is also increasing, presenting huge challenges and opportunities to the research and development community to find alternative treatments to manage these diseases.
Chronic inflammatory skin disorders like eczema, psoriasis and seborrheic dermatitis present one or more of the symptoms including redness, skin edema, itching and dryness, with possible crusting, flaking, blistering, cracking, oozing or bleeding on the disease site. In any skin clinic, patients with chronic inflammatory disorders presenting the symptoms of eczema, psoriasis and seborrheic dermatitis will represent about 60% to 80% of the cases. Prevalence varies from country to country ranging from 25-75 per thousand of population. In the United States alone the National Institute of Health estimates that 31.6 million people have some form of eczema [A Population-Based Survey of Eczema Prevalence in the United States, Jon M. Hanifin; Michael L. Reed; Dermatitis. 2007; 18(2):82-91], The National Psoriasis Foundation estimates that the prevalence of psoriasis in western populations is around 2-3% [Benchmark survey on psoriasis and psoriatic arthritis—summary of top-line results, National Psoriasis Foundation, www.psoriasis.org].
Histologically, dermal vessel changes are marked in all stages of the diseases: vascular dilatation, tortuosity, and lymphohistiocytic proliferation. In the acute oozing stage, spongiosis is predominant. In the sub-acute moist stage, spongiosis is less in evidence and acanthosis is more predominant. In the chronic thickened stage, dermal vessel dilatation, dermal vessel tortuosity and lymphohistiocytic proliferation are seen. Common symptoms observed with eczema, psoriasis and seborrheic dermatitis may include one or more of the following: erythema, pain, pustules, dermal vessel tortuosity, spongiform pustules, granular stratulosum, skin edema, itching and dryness, with possible crusting, flaking, blistering, cracking, oozing or bleeding on the disease site. [http://en.wikipedia.org].
There are numerous therapies in the field of allopathy medicine:    Hoare C., Li Wan Po A., Williams H. (2000) Systematic reviews of treatments for atopic eczema. Health Technology Assessment 4, 1-191.    Lee, N. P., Arriola, E. R. (1999) Topical corticosteroids: back to basics. Western Journal of Medicine, 171(5-6), 351-353.    Janniger C K, Schwartz R A. Seborrheic dermatitis. Am Fam Physician (1995) 52:149-55, 159-60 [published erratum appears in Am Fam Physician 1995; 52:782]    Schwartz R, Janusz C, Janniger C (2006). “Seborrheic dermatitis: an overview”. Am Fam Physician 74 (1): 125-30.    Scheinfeld N. (2005) Seborrheic dermatitis. Skinmed 4 (1): 49-50.    Luba K M, Stulberg D L. (2006) Chronic plaque psoriasis. American Family Physician 73 (4): 636-44.    Lebwohl M, Ting P T, Koo J Y M. (2005) Psoriasis treatment: traditional therapy. Ann Rheum Dis. 64 (Suppl 2).    Griffiths C E, Voorhees J J. (1996). Psoriasis, T cells and autoimmunity. J R Soc Med. 89 (6): 315-9.    Hunziker T, Schmidli J. Psoriasis, an autoimmune disease? Ther Umsch. (1993 February) 50(2):110-3.    Krueger G, Ellis C. Psoriasis-recent advances in understanding its pathogenesis and treatment. J Am Acad Dermatol. (2005) 53(1 Suppl 1):S94-100.    Lebwohl, M. Innovations in the treatment of psoriasis. Journal of the American Academy of Dermatology. (2004 July) 51(1)S40-41.    National Psoriasis Foundation. Psoriasis and Psoriatic Arthritis: Treatment Guide for the Health Insurance Industry. (2004) Treatment of psoriasis—Part 1—Topical Therapy and Phototherapy.    Lebwohl, M. et al, American Academy of Dermatology (October 2001) 45 (4). Treatment of psoriasis—part 2—Systemic therapies.    Lebwohl, M. et al, American Academy of Dermatology (November 2001) 45 (5); The immunological basis for the treatment of psoriasis with new biological agents.    James. G. krueger, M.D, American Academy of Dermatology (June 2002) 46, (1), 1-26; New psoriasis treatments based upon a deeper understanding of the pathogenesis of psoriasis vulgaris and psoriatic arthritis.    Callen, J. P. et al; American Academy of Dermatology, (August 2003) 49 (5), 351-356.
The treatments have been researched and developed to regress one or more symptoms of Itching erythema, pustule, pain, dermal vessel tortuosity, spongiform pustules, granular stratulosum, scaling, oozing and other symptoms common to the chronic inflammatory disorders eczema, psoriasis and seborrheic dermatitis. However, most of these therapies provide only temporary symptomatic relief and are either unsatisfactory or very expensive [National Psoriasis Conference, Boston Plaza Hotel, Aug. 5-8, 2005, Boston, Mass., USA; Wound Care Conference, Tampa, Fla., May 2007.] The therapies are associated with either short term or long term undesired side effect profiles. Herbal formulations are well known to minimize the risk of undesired side effect profiles and hence provide a viable alternative therapy to manage these disease conditions.
Research efforts to develop herbal formulations to treat these disease conditions have been on the rise.    Chopra, R. N., Nayar, S. C., and Chopra I. C., Glossary of Indian Medicinal Plants, C.S.I.R., P. 259 (1956).    Murugesa Mudaliar, K. S., Gunapadam Material Medica: Vegetable Section, Govt. of TamilNadu, P. 527 (1969).    Venkatarajan, S., Sarabendra Vaithiya Muraigal, P. 160, 161, 167 (1965).    Wealth of India, Raw Materials, Vol. X, P. 588-590, CSIR., New Delhi (1976); Yugimuni Vaidya Chintamani (800) Stanza 494-518, B. Rathina Nayakar & Sons, Viadras, India;    Nair, C. P. R., Kurup, P. B., Pillai, K. G. B., Geetha, A Ramiah, N., Effect of Nimbidin in Psoriasis, Indian Medical Journal, October 1978.    Indian Medicinal Plants: A Compendium of 500 Species, Vol. 1-5, Edited by P K. Warrier, V P K. Nambiar & C. RamanKutty, Published by Orient Longman (P) Ltd., 1994.
There is a continuing need to develop herbal formulations that are safe and are effective in the regression of chronic inflammatory skin disorders such as eczema, psoriasis and seborrheic dermatitis, formulations that have minimal or no side effects when used as directed.
The invention of this patent provides herbal formulations prepared from Wrightia tinctoria, Salix I., Tragia involucrata L. and Cocos nucifera that were tested on humans and clinically proved to be safe when used as directed and effective in treating the regression of chronic inflammatory skin disorders such as eczema, psoriasis and seborrheic dermatitis.